MAUDE Adverse Event Report: GIVEN IMAGING, INC. BRAVO PH CAPSULE DELIVERY DEVICE; ELECTRODE, PH, STOMACH

Lot Number 48086F

Device Problem Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2020

Event Type  malfunction  

Event Description

Patient scheduled for procedure egd with bravo ph capsule placement with anesthesia.Gi doctor performed egd and proceeded to deploy bravo capsule in the esophagus as planned.When endoscope was being withdrawn from patient it was realized the capsule did not deploy as it should have.After discussion with the gi doctor, all of the appropriate steps were followed in order to deploy the capsule and suction equipment that is required for capsule placement was functioning properly.Gi doctor re introduced endoscope in attempts to retrieve the capsule and it was found in the patients airway and due to patients cough reflex ended up in the nasopharynx.Ent was called emergently to assist in retrieving the capsule from the nasopharynx and was eventually successful in the retrieval.Anesthesia had to emergently intubate patient in order to protect airway for retrieval of capsule.Rep for bravo contacted and event discussed with her.She will report this event to the company and will be in to evaluate the deployment device and has stated that she will come in to provide education regarding the procedure and will be present in future cases to provide support.

• Brand Name: BRAVO PH CAPSULE DELIVERY DEVICE
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9711006
• MDR Text Key: 179420151
• Report Number: 9711006
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 48086F
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/28/2020
• Date Report to Manufacturer: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20440 DA